NCT07265141

Brief Summary

Clinicians will complete a screen-based automated virtual reality training intervention to learn how to counsel caregivers of pediatric patients on secure firearm storage.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

June 13, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

June 13, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

virtual realityMedical EducationGun violence prevention

Outcome Measures

Primary Outcomes (3)

  • Acceptability of Intervention Measure

    Four items, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better acceptability

    From completion of the virtual reality intervention to 2 months

  • Appropriateness of the Intervention Measure

    Four items, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better appropriateness

    From completion of the virtual reality intervention to 2 months

  • Feasibility of the Intervention Measure

    Four items, Scale score is average across individual items, Minimum score: 1, Maximum score: 5. higher scores indicate better feasibility

    From completion of the virtual reality intervention to 2 months

Secondary Outcomes (4)

  • De Novo Survey Item for Assessing Social Cognitive Theory Construct Behavioral Capability

    From completion of the virtual reality intervention to 2 months

  • De Novo Survey Items for Assessing Social Cognitive Theory Construct Self-Efficacy

    From completion of the virtual reality intervention to 2 months

  • De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectations

    From completion of the virtual reality intervention to 2 months

  • De Novo Survey Items for Assessing Social Cognitive Theory Construct Expectancies

    From completion of the virtual reality intervention to 2 months

Other Outcomes (1)

  • De Novo Standardized Patient Encounter Assessment Tool - Assessing Fidelity to the Virtual Reality Intervention Components

    From completion of the virtual reality intervention to 6 months

Study Arms (1)

An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians

EXPERIMENTAL

The automated virtual reality intervention allows clinicians to deliberately practice firearm safety counseling skills through verbal interactions with virtual characters with receipt of immediate feedback to support behavior change and mastery learning.

Behavioral: An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians

Interventions

The automated virtual reality intervention allows clinicians to deliberately practice firearm safety counseling skills through verbal interactions with virtual characters with receipt of immediate feedback.

An Automated Virtual Reality Intervention to Support Firearm Safety Counseling in Clinicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Unable to read and write in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (3)

  • March M, Zackoff M, Fleck J, Meisman A, Humphrey K, MacDougall MC, Ehrlich S, Griggs C, Sacks C, Masiakos P, Klein M, Real F. A Randomized Trial of Virtual Reality Training to Improve Firearm Safety Counseling Skills. Acad Pediatr. 2025 Jan-Feb;25(1):102560. doi: 10.1016/j.acap.2024.08.005. Epub 2024 Aug 10.

    PMID: 39128562BACKGROUND
  • Real FJ, Griggs C, March M, Masiakos PT, Meisman A, Felopulos G, Sacks CA, Zackoff MW. Feasibility and Acceptability of a Virtual Reality Curriculum to Support Firearm Safety Counseling Skills Among Pediatric Residents. J Grad Med Educ. 2024 Dec;16(6):740-746. doi: 10.4300/JGME-D-24-00022.1. Epub 2024 Dec 13.

    PMID: 39677314BACKGROUND
  • March ML, Meisman AR, Zackoff MW, Klein MD, Real FJ. Caregivers' and Community Members' Perspectives on Firearm Safety Screening and Counseling During Pediatric Primary Care Visits. J Pediatr Clin Pract. 2024 Mar 14;12:200099. doi: 10.1016/j.jpedcp.2024.200099. eCollection 2024 Jun.

    PMID: 39949418BACKGROUND

Central Study Contacts

Francis J Real, MD, MEd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 13, 2025

First Posted

December 4, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

December 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) for survey data will include clinician participants' (a maximum of n=30) demographic data (race, age, gender, role, practice setting, experience counseling on firearm safety), responses to items related to implementation (acceptability, appropriateness, and feasibility), and responses to items related to psychosocial constructs (behavioral capability, self-efficacy, expectations and expectancies). Data will include demographic information, baseline characteristics, outcome measures, and adverse event data. Access will be granted to researchers with a methodologically sound proposal, subject to review by the study team and institutional policies. Data be to be shared will be archived in DASH through the NICHD repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data access included in associated publications or the end of the award period, whichever comes first.
Access Criteria
Requests for data access should be submitted to the Principal Investigator or through the data sharing plan website.
More information

Locations